Registrieren

§ 374a SGB V has been in force since 2021, with its implementation deadline adjusted several times since due to missing technical specifications. The specifications – Health Device Data Transfer (HDDT) has been published by gematik in October 2025 for stakeholder commenting and are available since April 2026 as normative version 1.0.1. In parallel, BfArM has published interfaces and registration processes for the new device registry. With the upcoming GeDIG, the binding nature of these requirements are even strengthened, particularly by requesting the Establishment of a structured sanctions regime for non-compliance through the GKV-Spitzenverband. Having this organizational and technical ecosystem in place, it is now up to the manufactures of medical aids and implants to implement the requested services for sharing data with registered health apps (DiGA) by January 2028: